NCT06649760

Brief Summary

Refugees, facing forced displacement and often exposed to traumatic experiences, represent a vulnerable population with unique healthcare needs. Oral health is considered a prominent factor that contributes to quality of life. Therefore, this study aim at assessing the effect of message framing on enhancing oral health practices in a group of refugees in Alexandria, Egypt. A three-arm cluster randomized controlled clinical trial will compare a gain-framed mobile text messages group, a loss-framed mobile text messages group, and a control group. The primary outcome is the improvement in oral health practices measured by changes in dental plaque and secondary outcome is to assess change in oral health-related quality of life. In addition, oral health knowledge, attitudes, and practices of refugees will be assessed.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
510

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 29, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 21, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

October 21, 2024

Status Verified

October 1, 2024

Enrollment Period

6 months

First QC Date

October 12, 2024

Last Update Submit

October 17, 2024

Conditions

Keywords

Dental cariesPlaqueKAPGingivitis

Outcome Measures

Primary Outcomes (5)

  • Oral health knowledge improvement

    To assess change in level of oral health knowledge before and after program using a validated questionnaire

    Immediately after structured oral health session, 6 months and 1 year after baseline

  • Oral health practices improvement

    Assess toothbrushing and flossing frequency before and after the education session and reminder mobile messages

    6 months and 1 year after baseline

  • Oral hygiene status assesment

    measure the change in plaque index scores among participants

    6 months and 1 year after baseline

  • Gingival health assessment

    measure the change in gingival index scores among participants

    6 months and 1 year after baseline

  • Periodontal health status

    measure the change in CPI index scores among participants

    6 months and 1 year after baseline

Study Arms (3)

Gain-framed messages

EXPERIMENTAL

The participants will receive every 2 weeks a boosting reminder mobile text message in a gain-framed way. For example, "Great breath, healthy gums only a toothbrush away" "flossing your teeth daily removes particles of food in the mouth, avoiding bacteria, which promotes great breath."

Behavioral: Gain and loss framed mobile text messages

Loss-framed message

EXPERIMENTAL

he participants will receive every 2 weeks a boosting reminder mobile text message in a loss-framed way. For example, "Brush now and avoid bad breath and gum disease", "If you don't floss your teeth daily, particles of food remain in the mouth, collecting bacteria, which causes bad breath."

Behavioral: Gain and loss framed mobile text messages

Control group

NO INTERVENTION

Participants allocated to this group will not receive mobile text messages. They will only receive the oral health education session given to all participants at the beginning.

Interventions

To assess the effect of message framing on enhancing oral health practices in a group of refugees

Gain-framed messagesLoss-framed message

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Refugees older than 18 years old.
  • From Arabic speaking countries.
  • Has been resident in Alexandria, Egypt for at least 6 months.
  • Having mobile phones to receive text messages.
  • Agrees to participate in the study.

You may not qualify if:

  • Planning to move away during 1 year study period.
  • Participating in any kind of oral health education and promotion programs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Caritas

Alexandria, 21523, Egypt

RECRUITING

MeSH Terms

Conditions

BehaviorDental CariesDental PlaqueGingivitisPeriodontal PocketPlaque, Amyloid

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic DiseasesDental DepositsInfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitisPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Mona El Kashlan, Professor

    Alexandria University

    STUDY DIRECTOR

Central Study Contacts

Dina Attia, PhD student

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer, Dr.

Study Record Dates

First Submitted

October 12, 2024

First Posted

October 21, 2024

Study Start

June 29, 2024

Primary Completion

January 1, 2025

Study Completion

June 1, 2025

Last Updated

October 21, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Study protocol and assessment forms.

Locations